Director of Regulatory QA

Eurofins-posted 4 months ago

Full-time • Senior

Columbia, MO

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We are seeking a dynamic and experienced Sr. Director / Director of Regulatory & Quality Assurance to lead and oversee the strategic direction of our Quality Assurance, Quality Engineering, Metrology, Document Control and Training functions within a fast-paced pharmaceutical contract research organization (CRO). This role is responsible for guiding a team of functional managers to ensure regulatory compliance, operational excellence, and client satisfaction across all phases of drug development and testing. The ideal candidate will bring a strategic mindset, strong leadership capabilities, and a collaborative approach to drive continuous improvement and regulatory alignment across the organization. This is a high-impact role for a leader who thrives in a mission-driven, science-based environment.

Develop and maintain regulatory strategies, policies, and procedures to ensure compliance with FDA, EMA, ICH, and other global regulatory bodies.
Oversee regulatory submissions in collaboration with clients and internal stakeholders.
Ensure regulatory compliance in product labeling, advertising, and promotional materials.
Serve as the primary liaison with regulatory agencies and clients on compliance matters.
Support audits and inspections, including FDA, sponsor, and third-party audits.
Provide strategic leadership to managers overseeing Quality Assurance, Quality Engineering, Metrology, Document Control, and Training.
Ensure alignment of departmental goals with organizational objectives and regulatory expectations.
Mentor and develop managerial staff to foster leadership growth and operational excellence.
Promote cross-functional collaboration and accountability across quality and regulatory teams.
Guide the development and maintenance of the Quality Management System (QMS).
Ensure compliance with cGMP, GLP, and GCP standards across all testing and manufacturing activities.
Oversee audit readiness, CAPA programs, deviation investigations, and change control processes.
Drive continuous improvement initiatives and risk-based quality strategies.
Ensure proper calibration, maintenance, and qualification of laboratory and manufacturing equipment.
Oversee metrology systems to meet regulatory and operational requirements.
Collaborate with engineering and validation teams to support equipment lifecycle management.
Oversee the development and execution of a comprehensive training program to ensure staff competency and regulatory readiness.
Monitor training effectiveness and compliance across departments.
Foster a culture of quality, accountability, and continuous learning.
Partner with business development and operations to support client onboarding, audits, and project execution.
Provide regulatory and quality guidance during proposal development and project planning.
Contribute to strategy and client value proposition through quality and compliance excellence.

Bachelor’s or advanced degree in Life Sciences, Pharmacy, Engineering, or related field.
Minimum 10 years of experience in FDA-regulated industries (pharmaceutical, biotech, or CRO).
Prefer at least 3 years in a senior leadership role overseeing regulatory or quality functions.
Experience managing managers and cross-functional teams.
Proven track record in building and leading high-performing teams.
Deep knowledge of FDA, EMA, ICH, and other global regulatory frameworks.
Expertise in GMP, GLP, GCP, and ISO standards.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication, technical writing, and presentation abilities.
Proficiency in QMS, ERP systems, and Microsoft Office Suite.
Ability to manage multiple priorities in a deadline-driven environment.

Comprehensive medical coverage, dental, and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.

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